Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP

This study has been completed.
Sponsor:
Collaborators:
University of Oxford
Wellcome Trust
Information provided by:
European Malaria Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT00374998
First received: September 10, 2006
Last updated: February 28, 2007
Last verified: February 2007

September 10, 2006
February 28, 2007
April 2006
Not Provided
  • Immediate reactogenicity
  • Adverse events occurring before the end of the trial
  • Biological safety (haematological and biochemical indices)
Same as current
Complete list of historical versions of study NCT00374998 on ClinicalTrials.gov Archive Site
  • T-cell immunogenicity (prime-boost groups)
  • Humoral immunogenicity (prime-boost groups)
  • Gene expression (prime-boost groups)
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
A Phase I Study to Assess the Safety and Immunogenicity of the Polyprotein Malaria Vaccine Candidates FP9 PP and MVA PP in Healthy Adults Using a Prime-Boost Delivery Schedule

This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.

Malaria infection kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is clearly a great need for a safe effective malaria vaccine.

The purpose of this study is to test two candidate malaria vaccines (FP9-PP and MVA-PP) in different concentrations and combinations. These live viral vectors encode a ’polyprotein’ of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle. MVA-PP uses the Modified Virus Ankara vector, a weakened form of the smallpox vaccine, vaccinia. FP9-PP uses a highly attenuated avian pox virus (FP9) as the vector instead. The two vaccines will be used in combination in a ’prime boost’ strategy to enhance the response of the cellular immune system.

This study will:

  1. Examine safety
  2. Examine immunogenicity
  3. Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Malaria, Falciparum
  • Malaria
  • Biological: FP9-PP (FP9 polyprotein)
  • Biological: MVA-PP (Modified Virus Ankara polyprotein)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
January 2007
Not Provided

Inclusion Criteria:

  • Healthy adults aged 18 to 50 years
  • Resident in or near Oxford, UK for the duration of the vaccination study
  • Willingness to allow the investigators to access hospital and General Practitioner medical notes
  • For females only, willingness to practice continuous effective contraception during the study and if participating, during the subsequent challenge study.
  • Agreement to refrain from blood donation during the course of the study
  • Written informed consent
  • Willingness to undergo an HIV test

Exclusion Criteria:

  • Any deviation from the protocol-defined normal range in biochemistry or haematology blood tests or in urine analysis
  • Prior receipt of an investigational malaria vaccine
  • Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
  • Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination
  • History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet within 2 weeks prior to the challenge
  • Any history of malaria
  • Travel to a malaria endemic country within the previous 6 months prior to the planned challenge
  • Planned travel to malarious areas during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • Evidence of cardiovascular disease
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of haemoglobinopathies
  • History of diabetes mellitus
  • Chronic or active neurological disease
  • Chronic gastrointestinal disease
  • History of more than 2 hospitalisations for invasive bacterial infections
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness
  • Evidence of serious psychiatric condition
  • Any other on-going chronic illness requiring hospital specialist supervision
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00374998
VAC027.1, EudraCT number: 2004-002424-17, EMVI trial identifier: PP_1_04
Not Provided
Not Provided
European Malaria Vaccine Initiative
  • University of Oxford
  • Wellcome Trust
Principal Investigator: Adrian VS Hill, MA, BM BCh, DPhil, DM University of Oxford
European Malaria Vaccine Initiative
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP